Addressing stress for women entrepreneurs in Ethiopia: a randomized controlled study

Last registered on July 29, 2024

Pre-Trial

Trial Information

General Information

Title
Addressing stress for women entrepreneurs in Ethiopia: a randomized controlled study
RCT ID
AEARCTR-0014026
Initial registration date
July 20, 2024

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
July 29, 2024, 4:30 PM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

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Primary Investigator

Affiliation
Central Bank of Ireland

Other Primary Investigator(s)

PI Affiliation
World Bank Group
PI Affiliation
World Bank Group
PI Affiliation
Addis Ababa University

Additional Trial Information

Status
On going
Start date
2023-03-18
End date
2026-06-01
Secondary IDs
Prior work
This trial is based on or builds upon one or more prior RCTs.
Abstract
According to the UN report on ‘COVID-19 and the Need for Mental Health Action’ the “global economy loses more than US$ 1 trillion per year due to depression and anxiety”. Mental health problems, stress, and distress among women are likely to have increased during the COVID-19 pandemic and exacerbated by the conflict in Ethiopia. This study aims to evaluate the impact of the “Doing What Matters in Times of Stress Guided Self-Help Manual” on mental distress, business performance, and experience of intimate partner violence among women entrepreneurs in Ethiopia. The findings of this study will contribute to the emerging literature on the impact of mindset-oriented interventions on business performance of women entrepreneurs. Additionally, it will contribute to the evidence base on the links between mental distress and women’s probability of experiencing or re-experiencing IPV.
External Link(s)

Registration Citation

Citation
Hagos Hailemicheal, Adiam et al. 2024. "Addressing stress for women entrepreneurs in Ethiopia: a randomized controlled study ." AEA RCT Registry. July 29. https://doi.org/10.1257/rct.14026-1.0
Experimental Details

Interventions

Intervention(s)
The primary intervention under study is a brief Acceptance and Commitment Therapy based training designed to reduce mental distress amongst high-risk populations. The study posits that the implementation of this intervention will lead to a reduction in mental distress and probable depression. This is informed by evidence from similar interventions that have found impacts on stress and distress (Tol et al. 2020), depression, and food-insecurity (Vlassopoulos et al. 2021). Moreover, the intervention would decrease the experience of Intimate Partner Violence by improving relationship quality, self-esteem, and self-regulation (Greene et al., 2019; Iverson et al.,2011; Tol et al.,2020).
Intervention Start Date
2023-04-03
Intervention End Date
2023-06-25

Primary Outcomes

Primary Outcomes (end points)
Mental Health Outcomes
1.Kessler Psychological Distress Scale (K-6) - Respondent’s score on questions measuring distress in the previous 30 days.
2. Perceived Stress - Respondent's score on frequency of stressful feelings and thoughts in the previous 30 days
3. Depression (PHQ-9) - Score on Patient Health Questionnaire and the intensity of feelings of distress

Business Performance
1. Survival of business - Current ownership of the business
2. Number of employees - Number of employees
3. Profits - Total profits of the business during the previous month (winsorised at 95%)

Intimate Partner Violence
1. Physical or Emotional violence - Dichotomous variable indicating if respondent experienced physical violence or emotional violence in the past 12 months
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
Secondary mental health outcomes
1. Well-being Index - Respondent’s score for the 5 questions measuring well-being in the previous two weeks (WHO).
2. WHODAS-2.0 (Disability) - Respondent’s score on questions measuring difficulty in performing day-to-day work and social participation in the previous 30 days
3. Self esteem - Respondent’s score on questions measuring self-esteem based on Rosenberg self esteem scale

Socio emotional skills
1. Grit Scale - Respondent’s score on their perceived perseverance and passion for long term goals
2. Self Control - Respondent’s score on their level of self control
3. Self-efficacy - Respondent’s score on their level of self efficacy

Intimate Partner Violence

1. Physical violence - Dichotomous variable indicating if respondent experienced physical violence in the past 12 months
2. Emotional violence - Dichotomous variable indicating if respondent experienced emotional violence in the past 12 months
3. Attitude towards IPV - Scale measuring respondent’s agreement to wife beating

Secondary Business Performance
1. Number of hours worked in business - Number of hours worked in business previous week
2. Loans in arrears - Binary variable indicating if any loan by the respondent is in arrears
3. Savings - Savings in the previous seven days
4. Satisfaction with self-employment - Score measuring (1 to 10) satisfaction with self-employment

Entrepreneurial Outcomes

1. Entrepreneurial Orientation Index - Standardized index indicating innovativeness and risk-taking orientation of the respondent
2. Entrepreneurial Behavior Index - Standardized index indicating future planning work behavior and counter productive work behavior
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
We screened 6000 women via phone to identify 1200 eligible women for the study. An in-person baseline survey was then conducted with these 1200 women. After completion of the baseline survey, the study participants were randomized to either the Doing What Matters in Times of Stress (DWMTS) self-help manual intervention (n=596) or waitlist control (n=595), stratifying by city and marital status. We choose city as a stratification variable to account for potential heterogeneity across cities. We also stratify by marital status, considering some of the outcome variables, such as experience of IPV, are specific to married women. They were also allowed to invite a household member to join the sessions. This was followed by 7 phone-based sessions over 7 weeks to review handbook materials for the intervention group only.

We randomised the study participants at the individual level in four phases as batches of baseline data were received from the survey firm.
Experimental Design Details
Not available
Randomization Method
We randomised the study participants at the individual level in four phases as batches of baseline data were received from the survey firm using Stata.
Randomization Unit
Individual level randomization
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
No clusters in the study
Sample size: planned number of observations
1191 individuals
Sample size (or number of clusters) by treatment arms
Treatment group = 596 individuals, Control Group = 595 individuals
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
We computed the size of the minimum detectable effect (MDE) of the experimental design with the means and standard deviations of both the treatment and control groups of our baseline dataset. 1191 individuals were interviewed for the baseline survey. The randomised assignment allocated 596 women to the treatment group and 595 to the control group. We compute the minimum detectable effect for each of the outcome variables assuming 80 percent power and a significance level (𝛼) of 0.05. The MDEs for the psychological outcomes of the study vary between 5 percent and 15 percent. Similarly, the MDEs for business profits and number of employees range between 21.5 percent and 28 percent. Moreover, the MDE for the experience of any form of Intimate Partner Violence is 25.5 percent.
IRB

Institutional Review Boards (IRBs)

IRB Name
Ethiopian Public Health Association
IRB Approval Date
2023-03-16
IRB Approval Number
EPHA/OG/465/23
Analysis Plan

Analysis Plan Documents

Ethiopia Stress Management PAP_Final.docx

MD5: adceaafb1780cfa3dfbf13018f86a915

SHA1: 4925c4ac79b3a07ce0095403b87ad0fffbda2944

Uploaded At: July 20, 2024